YY/T 1518-2017C-peptide quantitative labelling immunoassay kit (English PDF)

4.7 Stability

4.7.1 General

Verify shelf life stability and thermal stability.

4.7.2 Shelf life stability

The manufacturer shall specify the period of validity of the product. Get the product within a certain period of time after the expiration date to test reagent blank limit, linearity, accuracy, intra-assay precision, specificity. The inspection results shall meet the requirements of 4.2, 4.3, 4.4, 4.5.1, and 4.6.

4.7.3 Thermal stability

Place the kit at 37°C for a certain period of time. Test reagent blank limit, linearity, accuracy, intra-assay precision, specificity. The test results shall meet the requirements of 4.2, 4.3, 4.4, 4.5.1, and 4.6.

4.7.4 Stability after lyophilization reagent reconstitution

After the lyophilized component in the kit is reconstituted according to the specified conditions, it is allowed to stand at 4°C for a certain period of time. Test reagent blank limit, linearity, accuracy, intra-assay precision, specificity.

The test results shall meet the requirements of 4.2, 4.3, 4.4, 4.5.1, and 4.6.

NOTE 1. Thermal stability cannot be used to derive the expiration date of a product unless it is based on a derivation formula based on a large number of stability studies.

NOTE 2. Generally, a product with a validity of one year is selected for no more than one month, a product with a validity period of no more than half a month for a half year, and so on. However, if the time exceeds the specified time, the product can be accepted when it meets the requirements.

NOTE 3. If the kit contains components such as lyophilized calibrators and is stable after being reconstituted for a certain period of time, verification of 4.7.4 is required.

5.1 Appearance

Visual inspection with normal or corrected visual acuity under natural light shall comply with the requirements of 4.1.

Where, CV - coefficient of variation; s - standard deviation of 10 measurements;

- average of 10 measurements.

5.5.2 Inter-assay precision

Repeat the determination of different concentrations of quality control products 10 times with three different batch kits. Calculate the coefficient of variation of the 30 measurements according to equation (3), which shall meet the requirements of 4.5.2.

Where, CV - coefficient of variation; s - standard deviation of 30 measurements;

- average of 30 measurements.

5.6 Specificity

Determine human proinsulin at a concentration of 10 ng/mL and human insulin sample at a concentration of 500 µL/mL, once respectively. The measurement results shall meet the requirements of 4.6.

5.7 Stability

After the kit is stored in accordance with the conditions specified in 4.7, the items of 5.2, 5.3, 5.4, 5.5.1, 5.6 shall be tested. The test results shall meet the requirements of 4.7.